Device to permit offpump beating heart coronary bypass surgery

ABSTRACT

Mechanical elements and/or adhesive is used in conjunction with or in place of suction to releasably attach elements of a system for manipulating a heart during cardiac surgery to the heart. The elements of the heart manipulation system are disclosed in the application Ser. No. 09/087,511 filed on May  29, 1998  and in the patent application Ser. No. 08/936,184 filed on Sept. 17, 1997. One form of the system can be used in minimally invasive surgery.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation-in-part application ofco-pending patent application Ser. No. 09/087,511 filed on May 29, 1998,which is a continuation-in-part application of Ser. No. 08/936,184 filedon Sep. 17, 1997 by the inventors of the present application. Thedisclosure of the just-referenced patent applications are incorporatedherein by reference.

TECHNICAL FIELD OF THE INVENTION

[0002] The present invention relates to the general art of cardiacsurgery, and to the particular field of heart retractors used in beatingheart surgery.

BACKGROUND OF THE INVENTION

[0003] There are as many as 300,000 coronary bypass graft proceduresperformed annually in the United States. Each of those procedures mayinclude one or more graft vessels. Currently, each graft vessel must behand sutured. As many as four or more grafts are placed in a procedure.Until recently, coronary artery bypass procedures have been performedwith the patient on cardiopulmonary bypass whereby the heart is stoppedwith cardioplegia and the surgery performed on an exposed and stillheart.

[0004] The previous applications disclosed means and methods formanipulating the heart during cardiac surgery whereby the heart can belocated and oriented into the most advantageous position and orientationfor beating heart surgery. Reference to those applications is made for amore complete discussion of the means and methods described.

[0005] Most particularly, the means and method described in thoseapplications include using a gross support to support the heart and ameans for engaging a selected section of the heart to immobilize thatselected section as a surgery target while permitting non-engagedsections of the heart to move in a manner whereby essentially unabatedcardiac output is maintained while the heart is regionally immobilized.

[0006] The gross support means disclosed in the application filed on May29, 1998 includes a flexible cup that can move in a plurality of planesand which has a flexible rim for engaging the heart. The cup isreleasably attached to the heart. One means for releasably attaching thecup to the heart includes suction applied by the cup to the heart.Suction is the best mode disclosed in the just-mentioned patentapplication.

[0007] As suction is readily available in most operating rooms, this isan effective means for releasably attaching the elements to the heart.However, this means can be improved.

[0008] Therefore, there is a need for a means and method for improvingthe releasable attachment between the elements of the heart manipulationsystem disclosed in the incorporated patent applications and the heart.

[0009] The suction system disclosed in the incorporated patentapplications can also benefit by being backed up whereby the heart willremain in the desired position and orientation even if vacuum is lost ordegraded.

[0010] Therefore, there is a need to provide a means for backing up thevacuum system used in the incorporated patent applications to releasablyattach the elements of the system to the heart.

[0011] Operation of the heart was discussed in the incorporated patentapplications and reference is made thereto for such disclosure so itwill not be repeated here.

[0012] Recently, there has been interest in minimally invasive coronarybypass surgery. This is not surprising since a median sternotomy and arun on the cardiopulmonary bypass pump are not well tolerated by somepatients, combined with the added cost of coronary bypass equipment andstaff. The procedure results in considerable recovery time and isassociated with a risk of death and major complication. While theultimate goal is to provide bypass to all vessels by port access (likegallbladder surgery) and to eliminate the need for cardiopulmonarybypass, a more limited but reasonable option for the next number oryears will be to perform bypass off pump with an incision (sternotomy orthoracotomy). A tool which could allow performance of multivessel offpump bypass would be most helpful.

[0013] Therefore, the incorporated patent applications disclosed a heartretractor which will support the heart in position for minimallyinvasive coronary bypass surgery of coronary arteries, including thecircumflex coronary artery, in a manner that will not damage the heartyet will provide easy access to the surgical target without requiringthe heart to be stopped yet without unduly constraining the heart.

[0014] These means and methods can also be improved by having additionalmeans and methods for releasably attaching the elements of the systemsto the heart during minimally invasive surgery.

OBJECTS OF THE INVENTION

[0015] It is main object of the present invention to improve theperformance of the system for manipulating a heart during cardiacsurgery which was disclosed in the incorporated patent applications.

[0016] It is-another object of the present invention to improve theperformance of the retractors disclosed in the parent disclosures.

[0017] It is another object of the present invention to improve theperformance of the retractors disclosed in the parent disclosures byproviding additional means for releasably attaching the elements ofthose systems to the heart.

[0018] It is a more specific object of the present invention to providemechanical means for releasably attaching elements of a system formanipulating a heart during cardiac surgery.

[0019] It is a more specific object of the present invention to provideadhesive means for releasably attaching elements of a system formanipulating a heart during cardiac surgery.

[0020] The objects set forth in the incorporated applications areincorporated herein by reference.

SUMMARY OF THE INVENTION

[0021] These, and other, objects are achieved by providing mechanicaland/or adhesive means for releasably attaching the elements of a systemfor manipulating a heart during cardiac surgery.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0022]FIG. 1 illustrates a suspension head mechanism such as disclosedin the incorporated patent application for lifting the heart.

[0023]FIG. 2 illustrates one mechanical means for releasably attachingthe suspension head to the heart as including a suture.

[0024]FIG. 3 illustrates one mechanical means for releasably attachingthe suspension head to the heart as including a staple.

[0025]FIG. 4 is another view of the staple shown in FIG. 3 in the formedcondition.

[0026]FIG. 5 illustrates a staple removing element.

[0027]FIG. 6 illustrates one mechanical means for releasably attachingthe suspension head to the heart as including a suture.

[0028]FIG. 7 is another form of the suture mechanical attaching meansshown in FIG. 6.

[0029]FIG. 8 illustrates an adhesive means for attaching an element ofthe heart manipulation system to the heart.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

[0030] The operation of a heart was discussed in the incorporated patentapplications, and reference thereto is made for such discussion.Furthermore, the discussion of the various elements of the heartmanipulation system were also fully discussed in the incorporatedmaterial, and reference is made thereto.

[0031] The improvement in the heart manipulation system which is thesubject of the present invention utilizes either mechanical or adhesivemeans to releasably attach an element of the heart manipulation systemto the heart. These means can be used in place of or in addition to themeans disclosed in the incorporated patent applications.

[0032] As shown in FIG. 1, a special cup 10 is used to attach variouselements of the heart manipulation system to the beating heart H in amanner that permits the heart and the myocardium to move during heartoperation without unduly affecting the attachment of the element to theheart. The cup 10 can be adapted to apply suction to the heart, but neednot and can be designed to have several degrees of freedom whereby theheart can move without undue restriction from cup 10. Specifically, cup10 has a flexible wall 12 and a flexible rim 14 and is attached to anarm 16 at an apex portion 18 of the cup. The flexible wall permits thecup to move in a plurality of planes so the heart can move relative toarm 16.

[0033] The means for releasably attaching cup 10 to the heart canincluded mechanical means. As used herein, the term “mechanical means”includes sutures, staples and other such mechanical elements andfasteners as opposed to suction and chemical means.

[0034] One form of mechanical means for releasably attaching elements ofthe heart manipulation system to the heart includes sutures 20. Sutures20 include needles 22 which are threaded through the heart manipulationsystem element, such as cup 10, and then through the heart tissue, andthen back through the heart tissue and back through the system elementand out of the patient. Sutures 20 can also include an element, such aspledget 24 for holding the suture in place on the heart and forspreading out the force applied by the suture to the heart tissue. Thesutures can be set in any manner known to those skilled in the art. Onceset, the sutures are tied off and then serve as a means for attachingthe system element to the heart. The sutures are cut when the element isto be released from the heart.

[0035] As shown in FIG. 1, the element, such as cup 10, can includeextensions, such as extension 26, having suture-accommodating holes 28defined therethrough. However, the element need not include theextensions, and the holes 28 can be defined in the element itself or thesutures can be drawn through the element without the need of such holes28 without departing from the scope of the present disclosure.

[0036] While the sutures are shown in FIG. 2 as extending through anextension on the element, these sutures could be sewn through theelement itself without departing from the scope of the presentinvention. In fact, the sutures need not be located near the perimeterof the element, but could be placed in any suitable location on theelement without departing from the scope of the present invention. Thesutures can be manipulated in any suitable manner and can take the formof any suture known to those skilled in the art without departing fromthe scope of the present disclosure. Those skilled in the art willunderstand what type of suture works best in any given application basedon their own knowledge and the teaching of the present invention and thepresent disclosure. Accordingly, the term “suture” is intended to coverany suture known to those skilled in the art that will work in theapplication disclosed herein.

[0037] Yet another form of mechanical means for releasably attaching anelement of the heart manipulation system to the heart is shown in FIGS.3 and 4 as including a staple 30. Staple 30 is set and formed accordingto known procedures from the unformed condition shown in FIG. 3 to theformed configuration shown in FIG. 4. Staples, such as those used toclose skin can also be used and still be within the teaching of thisinvention. An extension 32 is included on the heart manipulation systemelement, such as cup 10, and has a distal end 34 with a neck 36 definedtherein. A tab 38 is located on the distal end and includes a groove 40that permits a portion 41 of a staple removing tool, such as tool 42shown in FIG. 5, to be inserted beneath the staple for removing thatstaple from the formed configuration shown in FIG. 4. Once the staplesare removed, the element can be released from attachment to the heart.Portion 41 is manipulated by handle 44 via pivot 46 to unform the stapleto release the staple from the heart.

[0038] Yet another form of mechanical means is illustrated in FIGS. 6and 7 as a plurality of anchor wires 50 located inside the element beingreleasably attached to heart H. Each anchor wire 50 include a curled,pre-shaped end 52 which curls up inside the heart tissue once the wireis inserted into the tissue to fasten the element to the heart. Theanchor wires extend inside the element from apex 18 to and out of rim 14and the curled bias thereof is overcome by the inside surface of theelement as indicated at end 52′ shown in FIG. 6. The wire curls as itexits the element and enters the heart tissue. A plurality of wires canbe used as indicated in FIG. 7, and the wires can be used in conjunctionwith, or in place of, suction and/or other mechanical means, such as thesutures and/or staples disclosed hereinabove.

[0039] An adhesive means can also be used to releasably attach the heartmanipulation system element to the heart. As shown in FIG. 8, surgicaladhesive 60 can be placed on the element near rim 14 to releasablyattach the element to heart H. A wick 62 can be included in the elementto ensure the delivery of bonding activators or de-bonding agentsdirectly to the adhesive layer. Solvent can be applied to the adhesivevia wick 62 to release the adhesive from the heart as will occur tothose skilled in the art based on the teaching of the presentdisclosure. Any suitable surgical adhesive can be used and those skilledin the art will understand what adhesive is best based on the teachingof the present disclosure. In addition, heat or light or moisturesensitive adhesives could be used to releasably attach elements of theheart manipulation system to the heart without departing from the scopeof the present disclosure. The particular adhesive forms no part of thepresent invention and thus will not be discussed.

[0040] As is the case above, the adhesive can be used in conjunctionwith or in place of the suction and/or the mechanical means forreleasably attaching the element to the heart.

[0041] It is understood that while certain forms of the presentinvention have been illustrated and described herein, it is not to belimited to the specific forms or arrangements of parts described andshown. For example, tissue-gripping needles on a pad can be used toattach the elements of the heart manipulation system to the heart, suchtissue-grippng needles would be self-contained and quickly deployed.These needles would work in the manner of a skin stapler but would bemore convenient since they could deployed by a mechanism on theattachment element, Such needles can be anchored to the element beingattached to the heart, and released using tools similar to those used toremove small suture needles in other applications or have integrateddeployment or retraction means. The needles need not be formed with aformg device but can also be of a pre-formed configuration, such as ahelix, or the like and can be self-tapped into the heart. The heartattachment system is not dependent on suction alone and, as can beunderstood from the foregoing teaching, can include various other meansin addition to, or instead of, suction. Combinations of the variousmechanical and adhesive and suction means can be used as will beunderstood from the teaching of this disclosure.

We claim:
 1. A manipulation system for cardiac surgery comprising: agross support means for engaging a beating heart and supporting theheart when the heart is located and oriented for surgery, said grosssupport means being located at the base of the heart and including ahead which is sized and shaped to cradle the myocardium of the leftventricle along the arterialventricular groove; a suspension head forlifting the heart and which is located near the apical region of theheart and at least partially overlying the right ventricle; and meansfor releasably attaching said suspension head to the heart.
 2. In amanipulation system for cardiac surgery which includes means forengaging a selected section of the heart to immobilize that selectedsection as a surgery target while permitting non-engaged sections of theheart to move in a manner whereby essentially unabated cardiac output ismaintained while the heart is regionally immobilized, wherein theimprovement comprises: a suspension head means releasably attached tothe surface of the beating heart to lift the heart and which is locatednear the apical region of the heart, said suspension head including ahead abutting the surface of the beating heart, said head having meansfor accommodating multiplanar surface movement of the beating heartwhile remaining attached to the surface of the beating heart, saidsuspension head further including means for accommodating multiplanarmovement of the beating heart.
 3. The improvement defined in claim 1wherein said gross support means is located adjacent to the left atrium.4. A heart manipulation system for use in cardiac surgery comprising: aframe that is located inside a patient during beating heart surgery andwhich includes means for engaging the pericardial cavity of the patientfor mounting said frame on the patient to move with the patient if thepatient is moved or reoriented during surgery; a suspension head movablymounted on said frame for lifting the heart and which is located nearthe apical region of the right ventricle to prevent collapse of theright ventricle during manipulation of the heart and at least partiallyoverlying the right ventricle and which includes a flexible means forpermitting multiplanar relative movement between the beating heart andmeans mounting the suspension head on said frame means, said suspensionhead including a flexible rim engaging the myocardium of the heart andbeing flexible in a plurality of planes so multiplanar movement of themyocardium during operation of the heart will be accommodated by saidflexible rim; means for releasably attaching said suspension head to theheart; a means for locally engaging a selected section of the heart andlocally immobilizing the heart adjacent to a surgery target so the heartis supported and free to operate during surgery while it is also locallyimmobilized at the surgery target with non-engaged sections of the heartfree to move in a manner whereby essentially unabated cardiac output ismaintained while the heart is locally immobilized, and further includinga flexible rim engaging the myocardium of the heart and being flexiblein a plurality of planes so multiplanar movement of the myocardiumduring operation of the heart will be accommodated by the flexible rimof said means for locally engaging a selected section of the heart; agross support means movably mounted on said frame for engaging the heartto support the heart when the heart is oriented for surgery and which islocated at the base of the heart and which cradles the myocardium of theleft ventricle along the arterialventricular groove and which includesmeans for movably connecting said gross support means to said frame, thegross support means supporting the mitral valve annulus to maintaincompetent mitral valve function and is placed beneath an infoldedsection of myocardium, said gross support means including a handle whichextends outside of the patient during surgery for adjusting the locationof said gross support means, and further including a head having amalleable rod means for connecting said head to said means for mountingsaid gross support means on said frame, said head including a pluralityof sections which are movable relative to each other and means formaintaining said sections in a selected relative orientation; and meansfor releasably attaching said gross support means to the heart.
 5. Aheart manipulation system for use in cardiac surgery comprising: a framewhich is located inside a patient during beating heart surgery and whichis mounted on the patient to move with the patient; a suspension headmounted on said frame for lifting the beating heart and which includes aflexible head, said flexible head including a flexible rim, saidflexible rim being flexible in a plurality of planes to accommodatemultiplanar movement of the surface of the beating heart, and means foraccommodating multiplanar movement of the beating heart during beatingheart surgery; means for releasably attaching said suspension head tothe heart; and means for engaging a selected section of the heart toimmobilize that selected section as a surgery target while permittingnon-engaged sections of the heart to move in a manner wherebyessentially unabated cardiac output is maintained while the heart islocally immobilized.
 6. The improvement defined in claim 1 wherein theimprovement further includes means for engaging a selected section ofthe heart to immobilize that selected section as a surgery target whilepermitting non-engaged sections of the heart to move in a manner wherebyessentially unabated cardiac output is maintained while the heart isregionally immobilized.
 7. A manipulation system for use in cardiacsurgery comprising: a gross support means for engaging and supporting abeating heart when the heart is located and oriented for surgery andwhich is located at the base of the heart and engages the beating heartat a location that supports the mitral valve annulus and which includesa flexible head which is sized and shaped to extend along thearterialventricular groove-of the heart; means for immobilizing theheart adjacent to a surgery target so the heart is supported and free tooperate during surgery while it is also locally immobilized at thesurgery target; means for releasably attaching said gross support meansto the heart; and a suspension head for lifting the heart and which islocated near the apex of the heart and which includes a flexible head.8. The manipulation system defined in claim 1 wherein said means forreleasably attaching at least one of the suspension head or the grosssupport means to the heart includes sutures.
 9. The manipulation systemdefined in claim 1 wherein said means for releasably attaching at leastone of the suspension head or the gross support means to the heartincludes adhesive.
 10. The manipulation system defined in claim 1wherein said means for releasably attaching at least one of thesuspension head or the gross support means to the heart includesstaples.
 11. The heart manipulation system defined in claim 4 whereinsaid means for releasably attaching at least one of the suspension heador the gross support means to the heart includes sutures.
 12. The heartmanipulation system defined in claim 4 wherein said means for releasablyattaching at least one of the suspension head or the gross support meansto the heart includes adhesive.
 13. The heart manipulation systemdefined in claim 4 wherein said means for releasably attaching at leastone of the suspension head or the gross support means to the heartincludes staples.
 14. The heart manipulation system defined in claim 11further including an extension on a rim of the suspension head to whichsaid sutures are attached.
 15. The manipulation system defined in claim1 wherein said means for releasably attaching at least one of thesuspension head or the gross support means to the heart includes sutureneedles.
 16. The heart manipulation system defined in claim 4 whereinsaid means for releasably attaching at least one of the suspension heador the gross support means to the heart includes suture needles.
 17. Themanipulation system defined in claim 1 wherein said means for releasablyattaching at least one of the suspension head or the gross support meansto the heart includes mechanical elements.
 18. The heart manipulationsystem defined in claim 4 wherein said means for releasably attaching atleast one of the suspension head or the gross support means to the heartincludes mechanical elements.
 19. The manipulation system defined inclaim 1 further including a flexible means for permitting saidsuspension head to move in a plurality of planes to accommodate movementof the heart during beating of the heart to maintain cardiac output.